SINGLE PORT SURGICAL TISSUE CONTAINMENT AND EXTRACTION DEVICE
A tissue containment and extraction device including a tissue grasper configured to extend into a patient through an access site. The device includes jaws operative to grasp onto tissue to be extracted from the patient, and a tissue container having a distal end and a proximal end. The distal end of the grasper extends through the proximal end of the tissue container and is further operative to be extended through the distal end of the tissue container to grasp onto and pull the tissue proximally into the tissue container. A deployment structure is operatively coupled with the tissue container to allow a user to open the distal end of the container for receipt of the tissue and close the distal end of the container after the tissue is pulled into the tissue container. Related methods are also disclosed.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/252,861 filed on Oct. 19, 2009 (pending), the disclosure of which is hereby incorporated by reference in its entirety.
This generally relates to U.S. Pat. Nos. 6,610,072 and 6,152,936, the disclosures of which are fully incorporated by reference herein.
BACKGROUNDThis Invention relates generally to the art of surgery and in particular to the art of removing tissue from the patient during a surgical procedure. Many modern surgical procedures utilize small incisions or access sites through which endoscopic instruments are inserted to perform surgery in a minimally invasive manner. In some procedures it is necessary to ligate and remove tissue from a patient.
Quite often during a surgical procedure, tissue specimens are severed within the body cavity and then must be removed from the patient for diagnostic examination or for other reasons. For proper diagnosis it is imperative that the tissue in question be removed intact with as few lacerations or cuts as possible. This is because the pathologist must be able to report healthy tissue margins around diseased tissue. It is extremely difficult to try to reassemble any tissue which has been sectioned or mutilated prior to arrival at the histopathology lab. The surgeon removing the tissue is rarely in a position to help the pathologist try to re-assemble removed tissue bits. Therefore, it is advantageous that any tissue sample be removed from the body intact for diagnostic examination. However, this presents a particular problem when the incisions used for body cavity access are extremely small.
In minimally invasive procedures the surgeon uses the smallest access incision possible. However, if a tumor or other disease structure is found which needs to be biopsied or removed in its entirety, these incisions can be enlarged to a size just big enough to allow the tissue to be squeezed through the opening and removed from the patient cavity. This can create some cause for concern. For instance, if the tissue sample were to be cancerous in nature there have been studies that have shown that cancerous cells can be transferred to the access site while straining to pull the tumor through a small hole in the tissue. In such situations it is now common practice to attempt to enclose the tumor in a polyethylene bag while the excised tissue is still within the body cavity. Some advocate installing a plastic tube into the incision and drawing the tissue through the tube to protect the wall. When removing the tumor, the bag or tube becomes a barrier, which does not permit cells to dislodge and seed the patient's access site with cancer cells. As surgical instruments become smaller and smaller in diameter, it becomes more of a challenge for them to manipulate larger tissue samples.
While there are existing prior art “bag on a stick” type devices, they are very cumbersome to use. These devices, known as Endo-bags, are used to capture tissue and remove it from the patient. An Endo-bag is nothing more than a plastic bag with a purse string closure where the purse string tail is encased in a rigid plastic tube to facilitate deployment inside a body cavity. It is also important to understand how difficult it is to push a sample into a flaccid bag and close the bag without snagging the closure device on the grasper. In today's surgical procedures it is more and more commonplace to have only one surgical incision site. With more than one incision site the Endo-bag is somewhat easier to use because a separate grasper can be positioned desirably relative to the bag. That makes manipulation of tissue and insertion into the bag somewhat easier. However if the bag and grasper need to be in the same incision port—in other words parallel and in close proximity—it is almost impossible to manipulate the tissue into the bag and then close the bag. In addition it is very difficult to remove the bag without destroying the integrity of the bag while still inside the patient. The Endo-bag is also very difficult to direct through a trocar without tearing the bag. It would therefore be advantageous to provide a grasper and bag continuation system which makes a single port tissue extraction process easy and fast with less chance of contamination to the patient during extraction of the tissue sample.
The preferred embodiment of the disclosed device has a unique system for drawing the tissue into a tissue container, such as a tissue sample bag, by use of a grasper, such as a mechanical grasping structure or a suction wand. The grasper extends through the proximal end of the bag and an opening deployment structure is provided for opening and managing the distal end of the bag. The opening deployment structure assures a wide distal opening to obtain a large tissue access opening for the given bag size. In addition the deployment structure may act as a squeezing structure such as fingers to express out any unwanted fluids making the tissue as small as possible without harming the diagnostic integrity of the tissue during the extraction process. The device may be used in many ways such as, for example, extracting tissue samples for histopathological analysis or diagnosis, or for purposes of extracting tissue during other surgical procedures.
The device comprises a tissue container with proximal and distal ends and a wall, which may be generally cylindrical, between the proximal and distal ends. The proximal end has an elastic or otherwise grippable orifice. The grippable orifice may be a silicone O-ring or could be a small engagement element such as a purse string. This grippable orifice is adapted to be releasably retained on the shaft of the grasping tool used to introduce the tissue into the container, such as a flexible bag.
In its final assembly configuration, a mechanical grasper or a suction wand is inside the bag at the beginning of the procedure where it is positioned to be able to evert the bag (that is, turn the bag inside out) and draw the tissue into the proximal end of the bag. At the end of the procedure the grasper is withdrawn through the grippable orifice of the bag, which then closes on its own, or is otherwise closed, effectively sealing the proximal end of the bag. In an alternative embodiment, instead of the elastic orifice, a purse string tail could be pulled to tighten and close the proximal end of the bag.
The distal end of the bag incorporates a filament purse string attachment or closure around the perimeter of the opening. Around the perimeter of the bag are access scallops which allow deployment structure such as legs to snap onto the purse string element. In order for the device to be inserted through the abdominal or thoracic cavity the tissue bag is nested inside a hollow cavity created by the closing of the deployment structure. This creates the smallest circular cross-section so that the device may be introduced through a trocar into the patient. Once inside the patient, the grasper is advanced forward or distally, opening the deployment structure which, in turn, unfurl the tissue bag by pulling radially outward on the peripheral purse string filament.
Once a tissue bag is deployed and open, in one embodiment, four deployment structure legs hold the bag open to allow for easy access to the interior of the bag. The distal ends of the grasper jaws are now exposed at the proximal end of the tissue bag. As the grasper is further advanced through the proximal elastic or grippable orifice, the bag becomes everted. By further extending the grasper distally beyond the bag opening, one assures that by grasping the tissue and pulling it backwards or proximally into the bag opening that the tissue will remain at the deepest proximal point in the bag to allow full engagement inside the bag. The tissue may then be severed from whatever structure to which it is attached. The next step is to enclose the tissue in the bag. The distal purse string tail extends through the shaft of the tissue capturing device such as a cannula type structure into free space outside the patient's body. The surgeon grasps the handle of the tissue capturing device and pulls on the purse string tail. This closes the purse string at the distal end of the tissue bag. The deployment legs are releasably retained on the purse string with C-shaped snap type fittings. The legs, which are flexible, will track with the purse string as the purse string reduces in diameter. This action of the legs squeezes the contents of the bag and expressing any fluids. In the preferred embodiment the legs compress the tissue and hold the bag tightly enough to extract the sample from the body while still being enclosed by the legs. The legs help to guide the sample through the body wall.
As one alternative, once the purse string closure has become small enough, the snap fittings on the deployment legs will let go and release the bag from the instrument. At that point the grasper can be retracted fully, removing it from the proximal end of the bag through the elastic orifice. The elastic retainer, such as an O-ring, will close the hole which was left by the grasper. Now the tissue is inside the bag and is free from the device. The device may be removed from the patient through the trocar body. At the end of the procedure, after the trocar is removed, the surgeon will pull on the tail of the purse string and remove the bag containing the tissue through the patient's access site bringing it outside the body cavity.
In another alternative, a suction wand, in place of a mechanical grasper is used to draw the tissue into the bag. Once the tissue is drawn into the bag, the tissue can be released and the suction wand can be re-extended through the purse string opening to gather other tissue samples that need to be collected. One way retention features on the deployment legs, that extend into the inside of the bag, may be used to retain the tissue samples collected first and do not allow them to follow the suction wand out of the bag again as it is extended to collect other samples.
Various embodiments of this invention provide a tissue enclosing apparatus which can easily grasp and hold the subject tissue sample while facilitating the transfer of the tissue into a container through a single incision access port. The container can then be sealed off such as through use of a purse string type closure. With the grasper removed from the central lumen, the device will collapse onto the container facilitating withdrawal through the body cavity wall. Alternately, the container and tissue (contained inside) can be released from the device using the tail of the purse string that extends through the access site.
The instrument includes two basic components—the first being the tissue capturing and containing device; the second is a tissue grasper. Both have elongated shafts and handles at the proximal end of the instrument with tissue engaging features at the distal end. The tissue capturing and containing device has a hollow shaft with a central lumen which accepts the tissue grasper. The proximal end of the tissue grasper device has grip handles to facilitate manipulation of the distal end by use of one of the user's hands at the proximal end. Preferably, the grasper comes packaged with the device so that it interfaces well with the self-closing orifice at the proximal end of the tissue bag.
The tissue capturing bag 1 such as that shown in
In
If the user wishes to separate the bag 1 containing the tissue 28 from the instrument within the body cavity, the procedure would be as depicted in
In
While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features discussed herein may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of illustrative aspects and embodiments the present invention, along with the preferred methods of practicing the present invention as currently known.
Claims
1. A tissue containment and extraction device, comprising:
- a tissue grasper configured to extend into a patient through an access site, and including a distal end operative to grasp onto tissue to be extracted from the patient,
- a tissue container having a distal end and a proximal end, the distal end of the grasper extending through the proximal end of the tissue container and further operative to be extended through the distal end of the tissue container to grasp onto and pull the tissue proximally into the tissue container, and
- deployment structure operatively coupled with the tissue container to allow a user to open the distal end of the container for receipt of the tissue and close the distal end of the container after the tissue is pulled into the tissue container.
2. The device of claim 1, wherein the tissue grasper further comprises a mechanical grasping structure.
3. The device of claim 1, wherein the tissue grasper further comprises a suction wand.
4. The device of claim 1, wherein the tissue container further comprises a flexible bag providing a barrier to transmission of tissue cells during extraction of the tissue from the patient.
5. The device of claim 1, wherein the proximal end of the tissue container is configured to grip the tissue grasper.
6. The device of claim 5, wherein the proximal end of the tissue container is further configured to self-close upon removal of the tissue grasper from the proximal end of the tissue container.
7. The device of claim 1, wherein the tissue container turns inside out as the grasper is moved distally to grasp tissue and the tissue container returns to a normal configuration upon retraction of the grasper into the tissue container with tissue to be contained in the container and extracted from the patient.
8. The device of claim 1, wherein the deployment structure further comprises squeezing structure operative to reduce the size of the tissue and/or container prior to extraction from the patient.
9. The device of claim 1, wherein the distal end of the tissue container further comprises a purse string closure, wherein a tail of the purse string may be pulled by the user to close the distal end of the bag prior to extraction of the tissue and container from the patient.
10. The device of claim 9, wherein the purse string closure is releasably secured to the deployment structure to allow the tissue container and tissue contained therein to be removed as a separate unit from the patient.
11. The device of claim 1, further comprising a plurality of one way tissue retainers carried on the deployment structure and adapted to retain tissue within the container after the grasper has pulled the tissue proximally past the tissue retainers and into the tissue container.
12. A method for extracting and containing tissue from a patient, comprising:
- directing a tissue grasper into a patient through an access site of the patient and through a tissue container positioned within the patient,
- opening a distal end of the container,
- extending a distal end of the grasper beyond the distal end of the container,
- grasping tissue with a distal end of the grasper,
- pulling the tissue into the tissue container with the grasper,
- closing the distal end of the container with the tissue contained therein, and
- extracting the tissue container and tissue contained therein from the access site.
13. The method of claim 12, wherein grasping the tissue further comprises using a mechanical grasping structure or a suction wand.
14. The method of claim 12, further comprising:
- gripping the tissue grasper at a proximal end of the tissue container.
15. The method of claim 14, wherein extending the distal end of the grasper further comprises:
- turning the container inside out as the grasper is extended distally.
16. The method of claim 14, further comprising:
- removing the grasper from the proximal end of the container, and closing the proximal end of the container.
17. The method of claim 16, wherein closing the proximal end of the container further comprises:
- self-closing the proximal end of the container.
18. The method of claim 12, further comprising:
- squeezing the tissue and the container after the tissue is pulled into the container.
19. The method of claim 12, wherein closing the distal end of the container further comprises:
- pulling on a tail of a purse string closure coupled with the distal end of the container.
20. The method of claim 12, further comprising:
- using deployment structure to open and close the distal end of the container,
- releasing the container and tissue contained therein from the deployment structure and the grasper, and
- removing the tissue container and tissue contained therein from the patient as a unit separate from the deployment structure and the grasper.
21. The method of claim 12, further comprising:
- using deployment structure to open and close the distal end of the container, and
- using a plurality of one way tissue retainers carried on the deployment structure to retain tissue within the container after the grasper has pulled the tissue proximally past the tissue retainers and into the tissue container.
Type: Application
Filed: Oct 19, 2010
Publication Date: Aug 9, 2012
Applicant: WW7 L.L.C. (Marco Island, FL)
Inventor: Warren P. Williamson, IV (Loveland, OH)
Application Number: 13/501,540
International Classification: A61B 17/28 (20060101);